Catalog Number

C-ARM 5485M

Brand Name

PREFERRED MEDICAL PRODUCTS, LLC

Version/Model Number

C-ARM 5485M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K863853,K863853,K863853

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

93a07af4-cd8a-4b61-92aa-2157f8da410b

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2021

Package DI Number

10680211002931

Quantity per Package

20

Contains DI Package

00680211002934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX